Trial Outcomes & Findings for A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus (NCT NCT01438489)
NCT ID: NCT01438489
Last Updated: 2016-10-07
Results Overview
An SRI (4) responder defined as a participant who had 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of greater than or equal to (\>=) 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of \>= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index 'A' organ system score and no more than one new or worsening BILAG-2004 Index 'B' organ system score. OCS tapering requires a sustained reduction of OCS from Day 85 through Day 169 \[less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1\]. SRI was analyzed by a logistic regression model.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
626 participants
Primary outcome timeframe
Day 169
Results posted on
2016-10-07
Participant Flow
A total of 626 participants were screened out of which 319 participants did not meet eligibility criteria and were considered screen failures, and 307 participants were randomized into the study.
Participant milestones
| Measure |
Placebo
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
103
|
100
|
104
|
|
Overall Study
COMPLETED
|
77
|
84
|
85
|
|
Overall Study
NOT COMPLETED
|
26
|
16
|
19
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
11
|
3
|
8
|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Sponsor decision
|
4
|
1
|
4
|
|
Overall Study
Subject choice/Subject moved
|
2
|
1
|
1
|
|
Overall Study
Investigator decision
|
0
|
1
|
0
|
|
Overall Study
AE/SAEs
|
2
|
1
|
1
|
|
Overall Study
Received prohibited medication
|
1
|
0
|
0
|
|
Overall Study
Did not complete all 3 follow-up visits
|
2
|
5
|
2
|
|
Overall Study
Inadequate venous access
|
0
|
2
|
0
|
Baseline Characteristics
A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Placebo
n=103 Participants
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=100 Participants
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
n=104 Participants
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Total
n=307 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.2 Years
STANDARD_DEVIATION 12.9 • n=93 Participants
|
39.3 Years
STANDARD_DEVIATION 12.0 • n=4 Participants
|
40.8 Years
STANDARD_DEVIATION 11.6 • n=27 Participants
|
39.8 Years
STANDARD_DEVIATION 12.2 • n=483 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=93 Participants
|
94 Participants
n=4 Participants
|
99 Participants
n=27 Participants
|
287 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
41 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
41 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
128 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
36 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
109 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Multiple category checked
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Region of Enrollment
BRAZIL
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Region of Enrollment
BULGARIA
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Region of Enrollment
COLOMBIA
|
16 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
|
Region of Enrollment
CZECH REPUBLIC
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Region of Enrollment
HUNGARY
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Region of Enrollment
INDIA
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Region of Enrollment
MEXICO
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Region of Enrollment
PERU
|
15 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
50 Participants
n=483 Participants
|
|
Region of Enrollment
POLAND
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
|
Region of Enrollment
ROMANIA
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Region of Enrollment
TAIWAN
|
7 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Region of Enrollment
UKRAINE
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Region of Enrollment
UNITED STATES OF AMERICA
|
28 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
95 Participants
n=483 Participants
|
|
Baseline weight
|
68.08 kilogram
STANDARD_DEVIATION 18.98 • n=93 Participants
|
69.62 kilogram
STANDARD_DEVIATION 17.09 • n=4 Participants
|
70.74 kilogram
STANDARD_DEVIATION 17.29 • n=27 Participants
|
69.48 kilogram
STANDARD_DEVIATION 17.79 • n=483 Participants
|
PRIMARY outcome
Timeframe: Day 169Population: The modified Intent-To-Treat (mITT) population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies evaluable participants for this outcome measure.
An SRI (4) responder defined as a participant who had 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of greater than or equal to (\>=) 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of \>= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index 'A' organ system score and no more than one new or worsening BILAG-2004 Index 'B' organ system score. OCS tapering requires a sustained reduction of OCS from Day 85 through Day 169 \[less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1\]. SRI was analyzed by a logistic regression model.
Outcome measures
| Measure |
Placebo
n=102 Participants
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=99 Participants
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
n=104 Participants
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 169
|
17.6 Percentage of Participants
|
34.3 Percentage of Participants
|
28.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 169Population: The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies evaluable participants for this outcome measure.
Type I IFN signature in whole blood assessed by using a 4-gene diagnostic test. The blood samples collected were to be used to prospectively identify participants as IFN test-high or test-low. The results of this test were used to stratify participants. An SRI (4) Responder was defined as a participant who had 1) a reduction in baseline SLEDAI-2K disease activity score of \>= 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of \>= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system score. OCS tapering requires a sustained reduction of OCS from Day 85 through Day 169 \[less than 10 mg/day and less or equal to the dose received on Day 1\]. SRI was analyzed by a logistic regression model.
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=75 Participants
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
n=78 Participants
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Percentage of Type I Interferon (IFN) Test High Participants Achieving an Systemic Lupus Erythematosus Responder Index (SRI) (4) Response With Oral Corticosteroids (OCS) Tapering at Day 169
|
13.2 Percentage of Participants
|
36 Percentage of Participants
|
28.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 365Population: The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies evaluable participants for this outcome measure.
An SRI (4) Responder was defined as a participant who had 1) a reduction in baseline SLEDAI-2K disease activity score of \>= 4 points; 2) no worsening of disease from baseline as measured by the MDGA (worsening was defined as an increase of \>= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system score. OCS tapering requires a sustained reduction of OCS from Day 281 through Day 365 (less than 10 mg/day and less or equal to the dose received on Day 1). SRI was analyzed by a logistic regression model.
Outcome measures
| Measure |
Placebo
n=102 Participants
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=99 Participants
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
n=104 Participants
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 365
|
25.5 Percentage of Participants
|
51.5 Percentage of Participants
|
38.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 365Population: The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies evaluable participants for this outcome measure.
Participants on OCS \>=10 mg/day of prednisone or equivalent at baseline who were able to taper to \<= 7.5 mg/day at Day 365 were evaluated.
Outcome measures
| Measure |
Placebo
n=64 Participants
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=55 Participants
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
n=63 Participants
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Percentage of Participants on Oral Corticosteroids (OCS) >=10 mg/Day of Prednisone or Equivalent at Baseline Who Were Able to Taper to Less Than or Equal to (<=) 7.5 mg/Day at Day 365
|
26.6 Percentage of Participants
|
56.4 Percentage of Participants
|
31.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 422 (End of Study)Population: The safety population included participants who received any investigational product. Here, "N" signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group.
An adverse event (AE) was any untoward medical occurrence in a study participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. A serious AE (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly (in offspring of participant). AEs may be treatment emergent (TE) \[that is, occurring after initial receipt of investigational product\] or non-TE. An AESI is one of scientific and medical concern specific to understanding biologics and requires close monitoring and rapid communication by investigator to sponsor.
Outcome measures
| Measure |
Placebo
n=101 Participants
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=99 Participants
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
n=105 Participants
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
78 Participants
|
84 Participants
|
90 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
19 Participants
|
16 Participants
|
18 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs) and Treatment-Emergent Serious Adverse Events (TESAEs)
AESIs
|
12 Participants
|
10 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 422 (End of Study)Population: The safety population included participants who received any investigational product. Here, "N" signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group.
Any medically significant change in laboratory evaluations were recorded as Treatment emergent adverse events.
Outcome measures
| Measure |
Placebo
n=101 Participants
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=99 Participants
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
n=105 Participants
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Neutrophil count increased
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Leukocytosis
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Leukopenia
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Neutropenia
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Anaemia
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Iron deficiency anaemia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Lymphopenia
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Microcytic anaemia
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Thrombocytosis
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
White blood cell count increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Monocyte count increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Hypochromic anaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Hyperglycaemia
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Hypokalaemia
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Hepatic enzyme increased
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Hypocalcaemia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Lipid metabolism disorder
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Alanine aminotransferase increased
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Aspartate aminotransferase increased
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Blood creatine phosphokinase increased
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Hyperlipidaemia
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Hypertriglyceridaemia
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Hyponatraemia
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Blood alkaline phosphatase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Gamma-glutamyltransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Glomerular filtration rate decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Transaminases increased
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Dyslipidaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Alanine aminotransferase abnormal
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Aspartate aminotransferase abnormal
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Blood triglycerides abnormal
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Glomerular filtration rate increased
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 422 (End of Study)Population: The safety population included participants who received any investigational product. Here, "N" signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group.
Vital sign parameters are temperature, blood pressure, respiratory rate, heart rate and weight. Vital signs abnormalities were reported as TEAEs.
Outcome measures
| Measure |
Placebo
n=101 Participants
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=99 Participants
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
n=105 Participants
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Hypotension
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Secondary hypertension
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Weight increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Hypertension
|
7 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Pyrexia
|
5 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Blood pressure increased
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Blood pressure decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Blood pressure abnormal
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Chills
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Hypertensive emergency
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 422 (End of Study)Population: The safety population included participants who received any investigational product. Here, "N" signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group.
Any medically significant changes from the screening ECG was recorded as TEAEs. An abnormal ECG findings such as QT prolonged were reported as treatment emergent adverse events.
Outcome measures
| Measure |
Placebo
n=101 Participants
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=99 Participants
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
n=105 Participants
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 1, 85, 141, 169, 253, 337 (Treatment Phase), 365, 396, and 422 (Follow-up Period)Population: The safety population included participants who received any investigational product. Here, "N" and "n" signifies evaluable participants for this outcome measure and for specified category of the arms respectively. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in Anifrolumab 1000 mg group.
Anti-drug antibody responses to anifrolumab in serum were evaluated.
Outcome measures
| Measure |
Placebo
n=101 Participants
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=99 Participants
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
n=105 Participants
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)
Day 1 (n=100,98,105)
|
1.0 Percentage of Participants
|
1.0 Percentage of Participants
|
1.9 Percentage of Participants
|
|
Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)
Day 85 (n=91,93,98)
|
1.1 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)
Day 141 (n=84,94,93)
|
2.4 Percentage of Participants
|
0.0 Percentage of Participants
|
2.2 Percentage of Participants
|
|
Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)
Day 169 (n=81,89,92)
|
2.5 Percentage of Participants
|
0.0 Percentage of Participants
|
1.1 Percentage of Participants
|
|
Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)
Day 253 (n=72,86,86)
|
0.0 Percentage of Participants
|
1.2 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)
Day 337 (n=70,87,76)
|
0.0 Percentage of Participants
|
1.1 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)
Day 365 (n=85,96,94)
|
0.0 Percentage of Participants
|
1.0 Percentage of Participants
|
1.1 Percentage of Participants
|
|
Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)
Day 396 (n=78,88,90)
|
0.0 Percentage of Participants
|
2.3 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)
Day 422 (n=76,86,77)
|
1.3 Percentage of Participants
|
5.8 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)
Any Visit Post Baseline (n= 99,98,102)
|
3.0 Percentage of Participants
|
5.1 Percentage of Participants
|
2.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Days 29, 85, 141, 169, 253, 337 (treatment phase), on Days 365, 396, and 422 (follow up period)Population: The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies evaluable participants for this outcome measure and "n" signifies evaluable participants for the specified category of the arms respectively.
The PD positive and negative gene signature was determined by comparing the expression of type I IFN-inducible genes in a 21-gene panel in study participants relative to pooled normal blood collected from healthy participants.
Outcome measures
| Measure |
Placebo
n=102 Participants
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=99 Participants
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
n=104 Participants
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature
Day 29 (n= 68, 66, 73)
|
-0.753 Ratio
Standard Deviation 44.678
|
70.194 Ratio
Standard Deviation 40.028
|
82.056 Ratio
Standard Deviation 16.108
|
|
Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature
Day 85 (n= 63, 62, 72)
|
-5.412 Ratio
Standard Deviation 44.354
|
72.639 Ratio
Standard Deviation 34.443
|
79.350 Ratio
Standard Deviation 40.428
|
|
Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature
Day 141 (n= 59, 64, 68)
|
-25.411 Ratio
Standard Deviation 78.391
|
73.662 Ratio
Standard Deviation 36.684
|
88.569 Ratio
Standard Deviation 10.364
|
|
Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature
Day 169 (n= 56, 60, 66)
|
-17.122 Ratio
Standard Deviation 67.603
|
77.364 Ratio
Standard Deviation 30.733
|
88.126 Ratio
Standard Deviation 10.278
|
|
Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature
Day 253 (n= 50, 60, 61)
|
-9.908 Ratio
Standard Deviation 49.826
|
73.972 Ratio
Standard Deviation 41.267
|
86.099 Ratio
Standard Deviation 15.615
|
|
Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature
Day 337 (n= 49, 59, 53)
|
-13.784 Ratio
Standard Deviation 45.541
|
79.363 Ratio
Standard Deviation 28.803
|
87.811 Ratio
Standard Deviation 8.410
|
|
Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature
Day 365 (n= 58, 66, 68)
|
-6.428 Ratio
Standard Deviation 50.358
|
72.796 Ratio
Standard Deviation 35.552
|
81.115 Ratio
Standard Deviation 53.121
|
|
Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature
Day 396 (n= 56, 61, 64)
|
-22.106 Ratio
Standard Deviation 64.529
|
11.510 Ratio
Standard Deviation 56.385
|
72.291 Ratio
Standard Deviation 31.182
|
|
Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature
Day 422 (n= 53, 57, 55)
|
-31.777 Ratio
Standard Deviation 70.173
|
-0.836 Ratio
Standard Deviation 44.596
|
37.532 Ratio
Standard Deviation 66.339
|
SECONDARY outcome
Timeframe: Pre-infusion and 15 minutes post-infusion on Day 1, 169 and 337Population: The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, "N" signifies evaluable participants for this outcome measure and "n" signifies evaluable participants for the specified category of the arms respectively.
Maximum plasma concentration (Cmax) was defined as the peak plasma level of anifrolumab, derived from plasma concentration -time data.
Outcome measures
| Measure |
Placebo
n=98 Participants
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=104 Participants
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Anifrolumab at Day 1, 169 and 337
Day 1 (n=98,104)
|
82.8 micrograms/milliliter (mcg/mL)
Standard Deviation 64.5 • Interval 1.33 to 4.26
|
248 micrograms/milliliter (mcg/mL)
Standard Deviation 79.9
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Anifrolumab at Day 1, 169 and 337
Day 169 (n=86,87)
|
110 micrograms/milliliter (mcg/mL)
Standard Deviation 63.7
|
375 micrograms/milliliter (mcg/mL)
Standard Deviation 137
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Anifrolumab at Day 1, 169 and 337
Day 337 (n=83,67)
|
127 micrograms/milliliter (mcg/mL)
Standard Deviation 64.6
|
439 micrograms/milliliter (mcg/mL)
Standard Deviation 140
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion and 15 minutes post-infusion on Day 169 and 337Population: The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, "N" signifies evaluable participants for this outcome measure and "n" signifies evaluable participants for the specified category of the arms respectively.
Accumulation ratio for maximum plasma concentration (Cmax,AR) of anifrolumab after multiple administration at Day 169 and 337 was calculated.
Outcome measures
| Measure |
Placebo
n=81 Participants
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=86 Participants
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Accumulation Ratio of Maximum Observed Plasma Concentration (Cmax,AR) of Anifrolumab
Day 169 (n=81,86)
|
1.36 Ratio
Full Range 63.7 • Interval 0.0367 to 3680.0
|
1.43 Ratio
Full Range 137 • Interval 0.211 to 191.0
|
—
|
|
Accumulation Ratio of Maximum Observed Plasma Concentration (Cmax,AR) of Anifrolumab
Day 337 (n=78,66)
|
1.56 Ratio
Full Range 64.6 • Interval 0.132 to 7050.0
|
1.76 Ratio
Full Range 140 • Interval 0.492 to 240.0
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion and 15 minutes post-infusion on Day 29, 169 and 365Population: The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, "N" signifies evaluable participants for this outcome measure and "n" signifies evaluable participants for the specified category of the arms respectively.
Trough concentration (Ctrough) of anifrolumab at Day 29, 169 and 365 were calculated.
Outcome measures
| Measure |
Placebo
n=95 Participants
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=99 Participants
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Trough Concentration (Ctrough) of Anifrolumab at Day 29, 169 and 365
Day 29 (n=95,99)
|
7.95 microgram per milliliter
Standard Deviation 6.17 • Interval 0.0367 to 3680.0
|
46.8 microgram per milliliter
Standard Deviation 24.6 • Interval 0.211 to 191.0
|
—
|
|
Trough Concentration (Ctrough) of Anifrolumab at Day 29, 169 and 365
Day 169 (n=87,87)
|
18.4 microgram per milliliter
Standard Deviation 12.9 • Interval 0.132 to 7050.0
|
110 microgram per milliliter
Standard Deviation 60.5 • Interval 0.492 to 240.0
|
—
|
|
Trough Concentration (Ctrough) of Anifrolumab at Day 29, 169 and 365
Day 365 (n=83,71)
|
23.6 microgram per milliliter
Standard Deviation 15.5
|
154 microgram per milliliter
Standard Deviation 89.2
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion and 15 minutes post-infusion on Day 169 and 365Population: The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, "N" signifies evaluable participants for this outcome measure and "n" signifies evaluable participants for the specified category of the arms respectively.
Accumulation ratio for trough concentration (Ctrough,AR) of anifrolumab after multiple administration at Day 169 and 365 was calculated.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=86 Participants
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Accumulation Ratio of Trough Concentration (Ctrough,AR) of Anifrolumab at Day 169 and 365
Day 169 (n=82,86)
|
2.49 Ratio
Full Range 63.7 • Interval 0.0599 to 1250.0
|
2.29 Ratio
Full Range 137 • Interval 0.299 to 30.1
|
—
|
|
Accumulation Ratio of Trough Concentration (Ctrough,AR) of Anifrolumab at Day 169 and 365
Day 365 (n=79,70)
|
3.06 Ratio
Full Range 64.6 • Interval 0.00816 to 1130.0
|
3.02 Ratio
Full Range 140 • Interval 0.672 to 11.7
|
—
|
Adverse Events
Placebo
Serious events: 19 serious events
Other events: 36 other events
Deaths: 0 deaths
Anifrolumab 300 mg
Serious events: 16 serious events
Other events: 40 other events
Deaths: 0 deaths
Anifrolumab 1000 mg
Serious events: 18 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=101 participants at risk
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=99 participants at risk
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
n=105 participants at risk
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac tamponade
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.95%
1/105 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.99%
1/101 • Number of events 2 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Ear and labyrinth disorders
Vertigo
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Endocrine disorders
Goitre
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Eye disorders
Retinal disorder
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.95%
1/105 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Gastrointestinal disorders
Vomiting
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
General disorders
Chest pain
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
2.9%
3/105 • Number of events 3 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
General disorders
Oedema peripheral
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
General disorders
Pyrexia
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.95%
1/105 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Cellulitis
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Endocarditis
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Gastroenteritis
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.95%
1/105 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Influenza
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
2.0%
2/99 • Number of events 2 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.95%
1/105 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Lobar pneumonia
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Meningitis cryptococcal
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Peritonitis
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Pneumonia
|
2.0%
2/101 • Number of events 2 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
2.0%
2/99 • Number of events 2 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.9%
2/105 • Number of events 2 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Septic shock
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Subcutaneous abscess
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
5.9%
6/101 • Number of events 6 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
3.0%
3/99 • Number of events 3 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
2.9%
3/105 • Number of events 3 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.95%
1/105 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.95%
1/105 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Nervous system disorders
Cerebral infarction
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Nervous system disorders
Headache
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.9%
2/105 • Number of events 2 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Nervous system disorders
Ischaemic stroke
|
2.0%
2/101 • Number of events 2 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Nervous system disorders
Migraine
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Nervous system disorders
Myelitis transverse
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Renal and urinary disorders
Oedematous kidney
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
1.0%
1/99 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.95%
1/105 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Vascular disorders
Hypertensive emergency
|
0.99%
1/101 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Vascular disorders
Secondary hypertension
|
0.00%
0/101 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.95%
1/105 • Number of events 1 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Vascular disorders
Vasculitis
|
2.0%
2/101 • Number of events 3 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/99 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
0.00%
0/105 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
Other adverse events
| Measure |
Placebo
n=101 participants at risk
Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
|
Anifrolumab 300 mg
n=99 participants at risk
Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
Anifrolumab 1000 mg
n=105 participants at risk
Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
4/101 • Number of events 4 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
4.0%
4/99 • Number of events 5 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
7.6%
8/105 • Number of events 8 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Bronchitis
|
4.0%
4/101 • Number of events 4 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
7.1%
7/99 • Number of events 7 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
8.6%
9/105 • Number of events 11 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
4/101 • Number of events 4 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
12.1%
12/99 • Number of events 15 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
11.4%
12/105 • Number of events 20 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Upper respiratory tract infection
|
9.9%
10/101 • Number of events 13 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
12.1%
12/99 • Number of events 14 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
10.5%
11/105 • Number of events 20 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Infections and infestations
Urinary tract infection
|
10.9%
11/101 • Number of events 18 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
15.2%
15/99 • Number of events 16 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
6.7%
7/105 • Number of events 12 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
|
Nervous system disorders
Headache
|
12.9%
13/101 • Number of events 21 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
12.1%
12/99 • Number of events 14 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
11.4%
12/105 • Number of events 17 • Day 1 (Baseline) to Day 422 (End of Study)
1 participant from placebo arm inadvertently received one dose of anifrolumab 1000 milligram (mg).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER